Device Dossier

Airway, laryngeal, single-use

Device Dossier for Airway, laryngeal, single-use (Airway, laryngeal, single-use, Class IIa, sponsor Koala Medical). ARTG record, intended purpose, GMDN…

Intended purpose

A device used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases for spontaneously breathing and ventilated patients. It is inserted via the patients oral cavity preventing the tongue from obstructing the airway and an inflated cuff forms an airtight seal in the hypopharynx. Its construction will typically include a 15 mm patient connector, a curved airway tube, a pneumatic cuff, an inflation valve, a pilot balloon, and an inflation line. It may also contain a built-in drainage tube that allows expelled gastric content to bypass the pharynx, this specific feature decreases the rick of aspiration. It comes in various sizes and designs for both paediatric and adult use and is typically made of non-latex medical grade silicone and/or plastic materials and is a single-use device.

TGA Public Summary